Thousands of women have joined the lawsuit against Yaz, alleging that Yaz caused serious side effects including gallbladder damage and blood clots. Blood clots are serious health problems that can lead to heart attacks, strokes, pulmonary embolism, and even death.

Yaz, and other newer generation oral contraceptives that contain the hormone drospirenone such as Bayer’s Yasmin and generic varieties, were the subject of an FDA review last month based on new studies that suggested the pills put users at greater risk for blood clots than birth control pills made with other hormones. The committee fell short of recommending the drug’s withdrawal, opting instead to put stronger warnings on the pills’ packages.

Bayer’s attorneys have challenged Kessler’s expert witness credentials before in this MDL, and plan to do so again before the case goes to court.

There should be plenty of time for both sides to work on their cases. Earlier this month, U.S. District Judge David Herndon postponed the Yaz MDL’s bellwether trial. It was to have begun this month but was pushed back to April 20, 2012.

Source: Reuters

SOURCE: Yaz Lawsuit › Yaz lawyers oppose former FDA chief’s testimony

Consider this: The United States is one of only four countries that allow direct-to-consumer advertising. (The others are New Zealand, Bangladesh, and South Korea.) What the public is more apt to see or read about a drug is not breaking news or scientific studies, but rather advertiser-crafted sound bites or celebrity endorsements of medications heavily advertised on television and magazines.

Rather than relying on the guidance of a health care professional to determine the best drug for a patient, patients now enter doctor’s offices demanding a prescription for a drug to cure their latest ill.

The strategy is brilliant on the pharmaceutical companies’ end. Showcase the many benefits of a particular drug and consumers start asking for it by name – Viagra, Zoloft, Yaz. Suddenly consumers see cures for ailments they never even knew they had.

For example, Bayer, the maker of Yaz, marketed the birth control pill as more than an oral contraceptive. Its ads also focused on the drug’s ability to treat moderate acne and ease the symptoms of PMDD, the more serious form of PMS. Most women know PMS but aren’t aware how the condition differs from PMDD, so Bayer made identifying the condition easy by running ads with “checklists” that consumers could use to track their symptoms against the signs of PMDD.

These “checklists” have become a critical part of pharmaceutical companies’ marketing campaigns, and can be found on drug companies’ websites, on downloadable apps, and in brochures in doctors’ offices. They provide consumers with a powerful tool – the ability to diagnose their own conditions.

Yet, this tactic also provides drug companies with the power to influence patient preferences.

(This “checklist” marketing may explain why Americans spend nearly twice as much per person on prescription drugs than any other developed countries, and we account for nearly half of all sales of prescription drugs worldwide.)

Unfortunately, what these “checklists” often fail to do is point out who are not the best candidates for drugs. Yaz, the drug promoted as the miracle product for acne and PMDD, also carries a warning for blood clots. While all birth control pills carry a risk for this life threatening condition, new studies show that drospirenone, the hormone in Yaz, Yasmin, and some generic birth control pills, may put users at even greater risk for developing blood clots. Blood clots can lead to heart attacks, strokes, and pulmonary embolism, which can lead to death.

Source: New York Times

SOURCE: Yaz Lawsuit › Drug company ‘check lists’ influence patient choice

Hillard’s apparent conflict of interest on the federal agency panel was noted by former FDA Commissioner Dr. David Kessler, who recently offered expert witness testimony as part of an ongoing class-action lawsuit against the pharmaceutical company claiming that Bayer over-promoted the benefits and understated the risks of Yaz. Kessler also said that Bayer had plans to talk with Hillard about the risk of blood clots.

Hillard was also featured in a 2010 Bayer Tactical Brief video designed “to illustrate patient counseling techniques on the safety of Yaz.”

Blood clots are potentially deadly medical problems that can lead to strokes, heart attacks or pulmonary embolism. All birth control pills carry a slight risk for blood clots, which is noted on the drugs’ safety packaging. However, recent studies show that pills containing the hormone drospirenone put women at greater risk for developing blood clots. Bayer’s Yaz and Yasmin contain drospirenone. Bayer also makes versions of the pills with folic acid, known by the brand names Beyaz and Sayfral. Generic versions are also available.

The recent studies prompted the FDA to undergo a review of the safety of drospirenone-containing pills. The agency’s advisory panel voted to recommend that stronger warnings be put on the pills’ packages. Hilliard and at least three other members of the 26-member panel were later found to have research or financial ties to Bayer or companies that make generic versions of the pills.

In light of panel members’ possible conflict of interest in the Yaz case, citizen watchdog group POGO (Project On Government Oversight) is calling for a revote.

Source: California Watch

SOURCE: Yaz Lawsuit › FDA panel member ‘well utilized’ by Yaz maker

The order held at bay nine “bellwether trials” that would have paved the way for the mass settlement of more than 10,000 lawsuits against Bayer for its top selling birth control pills, Yaz and Yasmin. The lawsuits accuse Bayer of misleading women about the safety risks associated with its oral contraceptives.

Yaz and Yasmin are a newer generation of birth control pills that contain the hormone drospirenone. Since the drugs were introduced to the market, generic brands and other formulations of birth control pills containing drospirenone have entered the market.

All birth control pills carry a slight risk for blood clots, but new studies suggest that the risk is even greater with birth control pills that contain drospirenone. A Food and Drug Administration (FDA) expert panel recently reviewed the studies and recommended that the pills’ labels carry stronger warnings about the blood clot risk.

Yaz and Yasmin became the top selling birth control pills in the United States with a staggering $1.58 billion in sales in 2010.

Source: The Madison St. Clair Record

SOURCE: Yaz Lawsuit › First Yaz trial will be April 30 if mediation fails

The Project on Government Oversight (POGO), a non-partisan, non-profit government advocacy group, found that of the 26 advisers on the FDA panel, three had research or financial ties to Bayer, makers of the top selling oral contraceptives Yaz and Yasmin. All four of those panel members voted in favor of keeping drospirenone-containing pills on the market.

Drospirenone is a hormone that works like a diuretic. It is found in Yaz and Yasmin, as well as various generic brands. The drugs came under FDA review after recent studies that suggested the pills were more likely to cause blood clots than birth control pills made with other hormones.

This week, POGO sent a letter to the FDA asking for the pills to be reviewed again, this time by a new, better vetted, advisory panel. “The American public must be able to trust that the FDA and its advisory committees are making decisions based on science, not industry influence,” POGO Executive Director Danielle Brian said.

FDA advisory panels review studies and make recommendations to the federal agency. While the FDA generally follows the advice of its exert panels, it is not required to do so.

Source: MedPageToday

SOURCE: Yaz Lawsuit › FDA panel members had ties to Yaz maker

What he has yet to accomplish is the removal of the birth control pill Yaz. The newer generation oral contraceptive contains the hormone drospirenone, and recent studies show the pill may put women at even greater risk for developing deadly blood clots than pills with older hormones.

Blood clots can be deadly and can lead to serious complications such as heart attack, stroke and pulmonary embolism.

An FDA advisory panel recently reviewed the blood clot risk with drospirenone-containing pills and fell short of recommending the drug’s removal from the market. Instead, the panel supported placing stronger warnings on the pills’ packages. It was a tremendous disservice to the public, Wolfe asserts.

Bayer, maker of Yaz and its sister contraceptive Yasmin, launched advertising campaigns when the pills hit the market that made the birth control pills the top-selling brands in the country. The company has made billions on the sales of the pills. Yet, when questioned about mounting reports of serious injuries associated with the pills, Bayer continues to insist Yaz and Yasmin are no more dangerous than other birth control pills.

Bayer currently faces thousands of lawsuits from women who say they were not adequately warned by the drug company that the pills could make them seriously ill.

When the FDA panel voted last month whether to keep Yaz on the market, Wolfe had already waged a war against Yaz. In his “Worst Pills, Best Pills” newsletter, Yaz was listed as a “Do Not Use” drug. Instead of allowing Wolfe to stand up against the birth control pills, the committee pulled his right to vote, citing an “intellectual conflict of interest.”

Source: Salem-News

SOURCE: Yaz Lawsuit › FDA advisor warns ‘do not use’ Yaz, Yasmin

U.S. District Judge David Herndon ordered Bayer and lawyers for the defendant to meet with mediator Stephen Saltzburg, a Gerorge Washington University law professor, to explore a possible settlement.

Yaz and Yasmin are a newer generation of birth control pills that contain the hormone drospirenone. New studies have indicated that the pills may put women at greater risk for suffering blood clots than pills with older hormones. An advisory committee to the Food and Drug Administration (FDA) last month recommended that stronger warnings about the greater risk of blood clots be added to the drugs’ safety labels.

Blood clots are potentially life-threatening conditions. They can break free and travel through the bloodstream and lodge in the heart and cause heart attacks, in the brain and trigger a stroke, or in the lungs which can cause a pulmonary embolism. Thousands of women allege that Bayer did not adequately warn them that taking Yaz or Yasmin could be deadly.

Yaz and Yasmin became the top selling birth control pill in the United States, with $1.58 billion in sales in 2010 alone. Bayer issued a statement saying that while it continues to defend the litigation, the company is engaged in mediation and settlement discussion.

Source: Business Week

SOURCE: Yaz Lawsuit › First Yaz lawsuit ordered to mediation for potential settlement

Missing data

Lead researcher Joseph Ross said drug companies that delay publishing these findings, or even deliberately hide trial data, are breaching their ethical duty. “The evidence we publish shows that the current situation is a disservice to research participants, patients, health systems, and the whole endeavor of clinical medicine,” he said.

Data from these trials could provide vital information, such as evidence that a drug is dangerous. For example, Bayer faces lawsuits from women who say that the company was aware that its birth control pills Yaz and Yasmin put them at greater risk than other pills for suffering serious health problems, including blood clots, heart attacks, strokes and gallbladder damage. The company insisted that its oral contraceptives were no more dangerous than other pills. However, newly released studies show that the pills are more risky than older generation birth control pills.

In fact, during a Food and Drug Administration (FDA) advisory committee meeting reviewing the safety concerns associated with Yaz and Yasmin, the former FDA chief testified that Bayer withheld pertinent data on Yasmin and the increased risk for blood clots. (The committee recently recommended that stronger warnings be placed on the packages of Yaz and Yasmin, telling women that studies show the pills carry a greater risk for blood clots that can lead to serious health problems and even death.)

Yaz and Yasmin are among the top selling birth control pills in the United States and the United Kingdom; however, recent press about the drug’s link to blood clots has led to a drop in sales.

“Most clinicians assume that the complex regulatory systems that govern human research ensure that (clinical data) is relevant, reliable and properly disseminated,” Dr. Richard Lehman from Oxford University and the British Medical Journal’s Dr. Elizabeth Loder told the Daily Mail. “It generally comes as a shock to clinicians, and certainly to the public, to learn that this is far from the case.”

Sources:
Daily Mail
Bloomberg

SOURCE: Yaz Lawsuit › Drug companies may delay, withhold trial data from medical journals

Late last year, FDA advisory committees reviewed studies which suggested that birth control pills containing the hormone drospirenone put women at greater risk for blood clots than pills made with older-generation hormones. Blood clots are serious health problems because they can break loose and travel to the heart, lungs or brain causing serious complications or death.

Oral contraceptives that contain drospirenone are the top selling Yaz and Yasmin, as well as Safyral, Beyaz (all made by Bayer) and generics Gianvi, Loryna, Ocella, Syeda, and Zarah.

These claims have resulted in thousands of lawsuits against Bayer by women who say they were not adequately warned that using drospirenone-containing pills could put their life at risk.

The FDA committee fell short of recommending that the pills be banned, instead advising that stronger labels be placed on the pills.

The committee also recommended that stronger warnings be placed on the Ortho Evra birth control patch, made by Johnson & Johnson. Studies have linked the patch to high numbers of blood clots.

While many otherwise healthy women have suffered health problems as result of these contraceptives, experts say women with specific risk factors should probably avoid them altogether. This includes women with blood clotting disorders or a family history of blood clotting, smokers, and women over the age of 35.

Perhaps the best advice is to consider alternatives to birth control pills and patches. Options include the hormone shots and the increasingly popular intrauterine devices (IUDs), which are made in both hormone and non-hormone forms. And there are always more traditional methods, such as condoms, contraceptives sponges and diaphragms.

Source: Everyday Health

SOURCE: Yaz Lawsuit › Women should be aware of blood clot risk with birth control pills, patches

The study, released last month, puts the blood clot risk with drospirenone-containing pills at 43 to 65 percent greater when compared to pills with other types of hormones. The latest study is based on data from 330,000 Israeli women.

Previous research, involving 835,826 women ranging in age from 10 to 55 who were taking pills like Yaz, suggested the blood clot risk was as much as 74 percent greater with drospirenone pills compared to oral contraceptives containing older hormones.

All birth control pills carry a risk for blood clots, but the latest study provides more evidence that pills like Bayer’s Yaz and Yasmin may be even more dangerous. Blood clots can lead to serious complications such as strokes, heart attacks and even death. The pills have also been associated with gallbladder damage.

Other pills that contain drospirenone include Bayer’s Beyaz and Safyral. There are also numerous generic versions available.

Tens of thousands of lawsuits have been filed by women who say they have suffered serious injuries from the pills, and who say Bayer did not adequately warn them that using the pills could put their lives at risk.

A Food and Drug Administration (FDA) advisory committee recently recommended that stronger warnings be placed on the packages of oral contraceptives containing drospirenone.

Source: Beasley Allen Personal Injury Attorney

SOURCE: Yaz Lawsuit › New studies show increased risk of blood clots with Yaz

Yaz

Watson wants to take a bite out of the $173 million in sales Yaz has generated for the 12 months ended on September 30. The drug company is currently in a patent dispute with Bayer regarding Yaz.

Vestura joins others in this newer formulation of oral contraceptives that contain the hormone drospirenine. Others in this class include Yaz, Yasmin, Beyaz and Safyral.

An FDA advisory panel recently reviewed studies on the safety of drospirenone-containing pills that showed the pills appear to put users at greater risk for blood clots, heart attacks, strokes and even death. The pills have also been associated with gallbladder damage. The committee ultimately recommended stronger warnings be placed on the drugs’ packages. The FDA is not required to follow the advice of its advisory panels, but it usually does.

Bayer is currently embroiled in thousands of lawsuits over its family of drospirenone-containing pills from women who claim the drug company knew the drugs were dangerous but continued to sell them.

Source: WSJ

SOURCE: Yaz Lawsuit › FDA approves generic Yaz despite serious blood clot warnings

Bayer

The claim was made by former FDA commissioner David Kessler, who claimed Bayer did not include an analysis that demonstrated an increase in the U.S. reporting rate for blood clots in a 2004 review of Yasmin’s safety to the federal agency. The report also didn’t include an earlier draft opinion by Bayer researchers that identified a difference in blood clot rates for Yasmin compared to other oral contraceptives. Instead, he claimed Bayer chose to market Yasmin for the treatment of premenstrual syndrome, a condition for which the drug was not approved.

The report was part of an expert panel’s analysis of data that suggested that Yasmin and other birth control pills containing the hormone drospirenone put women at greater risk for life threatening blood clots than older oral contraceptives. Other pills that contain drospirenone include Bayer’s Yaz, Beyaz and Safyral. Generic varieties are also marketed in the United States.

Bayer is currently embroiled in thousands of lawsuits from women who say they were not adequately warned that using drospirenone-containing birth control pills could put them at risk for blood clots, heart attacks, strokes and even death. The drug company has insisted its birth control pills are no more as dangerous as other oral contraceptives.

The expert panel pored over data for nine hours, eventually voting to recommend that the FDA place stronger warnings for the risk of blood clots on the drug’s packaging. The agency is not required to follow the advice of its expert panels, but it usually does.

Source: Bloomberg

SOURCE: Yaz Lawsuit › Report: Bayer withheld data on blood clot risk with Yasmin

Yaz, made by Bayer, is a newer generation birth control pill that contains the manmade hormone drospirenone, which is designed to mimic the naturally occurring female hormone progesterone. The pill was heavily promoted as an oral contraceptive that could also clear up acne and remedy the bothersome symptoms of premenstrual syndrome. It soon became the nation’s top selling birth control pill.

Bayer has since been fined for making such claims and ordered to run revision ads. Other pills that contain drospirenone include Bayer’s Yasmin, Beyaz and Safyral. Generic varieties are also available.

All birth control pills have a slight risk for blood clots. But recent studies have suggested that the risk of blood clots with drospirenone is higher. Bayer currently faces thousands of lawsuits from women who say they were not adequately warned that using Yaz and pills like it could put them at risk for dangerous blood clots that can lead to stroke, heart attack and death.

The most recent studies convinced the FDA that the safety of drospirenone-containing pills needed a closer look.

Panelists spent more than nine hours discussing the data on blood clot risk with drospirenone pills compared to those with older hormones. While there was discrepancy on the authenticity of the studies, nearly the entire panel voted that the label should clearly state the potential for potentially fatal blood clots.

The fate of Yaz and its similar birth control pills now falls on the FDA. The agency is not required to follow the advice of its panels, but it usually does.

Source: Boston.com

SOURCE: Yaz Lawsuit › FDA panel recommends stricter blood clot warnings on Yaz

The new guidelines are based on data from a group of recent studies, and reveal the dangers of oral contraceptives immediately following birth may be much higher than previously thought. The risk of blood clots in women of reproductive age in general is low, but the risk increases significantly when these women are pregnant and for the first six weeks following delivery.

Estrogen-containing birth control pills already carry a slight risk for blood clots, but recent studies show that newer generations of birth control pills, such as Yaz and Yasmin that also contain the hormone drospirenone, may put women at even greater risk for developing blood clots. Yaz and Yasmin, made by Bayer, are among the most widely used birth control pills in the United States and Canada. The company currently faces more than 2,000 lawsuits from women that claim they were not adequately warned by Bayer that taking Yaz and Yasmin could put their lives at risk.

Source: MSNBC

SOURCE: Yaz Lawsuit › Birth control pills increase stroke risk after delivery

The story lauded contraceptives for their preventative benefits: “Women on birth control see a 60 percent decreased risk of ovarian cancer. There is also a 50 percent reduction in uterine cancer which has 37,000 new cases each year.” Yet, the story fails to mention the serious risks associated with Yaz, a newer generation birth control pill that combines the hormones ethinyl estradiol and drospirenone, as well as other birth control pills.

All birth control pills carry a slight risk for blood clots. But new studies suggest that some pills, especially those containing drospirenone, may put women at even greater risk for developing the condition. Blood clots are serious health problems that can lead to heart attacks, strokes, and even sudden death.

Last month, based on new studies published in the British Medical Journal, the FDA and Health Canada announced they were reviewing studies on the health risks associated with Yaz, Yasmin (also made with ethinyl estradiol and drospirenone) and their generic equivalents. Early reviews of the studies comparing oral contraceptives containing drospirenone with pills containing another progestin, indicate that drospirenone-containing pills may put women at greater risk for blood clots.

Bayer, the makers of Yaz and Yasmin, have held firm on the message that their pills are no more dangerous than other oral contraceptives. However, the company was ordered by the FDA this summer to add stronger blood clot warnings on the safety labels of both Yaz and Yasmin. Bayer also faces about 2,000 lawsuits from injured women who allege that they were not properly warned by the company that the pills could be deadly.

Still think the benefits of an acne-free face outweigh the risk of life-altering blood clots?

Source: Style Bistro

SOURCE: Yaz Lawsuit › Are birth control pills for acne treatment a good idea?

While the new Health and Human Services guidelines will make contraception affordable for all insured women, it also raises the importance for women to understand the risks and benefits of using birth control. Pharmaceutical companies use advertising to promote the benefit of their drugs, and the Food and Drug Administration (FDA) requires those advertisements to include possible side effects.

This consumer-targeted marketing has resulted in patients asking their doctors for specific drugs by name. The tactic worked such wonders for Bayer when it launched its birth control pill Yaz that the pill became the most prescribed oral contraceptive in the county.

Unfortunately, the drug company was cited for running ads that overstated the benefits of Yaz and didn’t clearly explain the possible life threatening risks associated with the pills. Bayer was ordered to rerun a series of ads explaining that, like all forms of birth control, Yaz puts women at slight risk for blood clots that can lead to heart attack, stroke, and death.

As the top-selling birth control pill in the country, Yaz was also creating another stir. An unusually high number of blood clots in women who were using the pills were being reported, which lead researchers to conduct a study comparing the hormones in Yaz to those in older generation birth control pills. They found that Yaz put women at greater risk of developing blood clots.

The study has prompted the FDA to conduct an ongoing review of data. The agency says it will offer a recommendation once all information has been reviewed.

Source: CNN

SOURCE: Yaz Lawsuit › Birth control soon to be free to all insured women

Generic drugs are what the Food and Drug Administration calls “copies of brand name drugs that have exactly the same dose, intended use, side effects, route of administration, risks, safety, and strength as the original drug.” However, the generic version, by law, is not entirely the same. It may have different colors or inactive ingredients. About half of all generic drugs are produced in the same plants used to manufacture the brand name drugs.

Yaz contains 3mg drospirenone and 20 mcg of ethinyl estradiol. Bayer offers the same formulation in Beyaz, a birth control pill that also contains the B vitamin folic acid. Generic versions of Yaz made by other manufacturers include Gianvi and Loryna.

Yasmin contains 3mg drospirenone and 30 mcg of ethinyl estradiol. Bayer also offers a folic acid-fortified version of Yasmin known by the brand name Safyral. Bayer also offers a generic Yasmin by the name of Ocella. Syeda and Zarah are more generic brands of Yasmin sold by other companies.

While all birth control pills put women at risk for blood clots, new studies show that drospirenone-containing pills put women at even greater risk. This includes Yaz and Yasmin, but also the numerous generic brands. Using a generic version of a medication does not mean, if you have been injured, that you are not eligible for compensation.

However,  a recent Supreme Court ruling determined makers of generic drugs are not required to warn patients if they receive reports of new side effects from the drugs. This ruling can protect generic drug makers from being sued under state liability laws for failing to warn patients of these new dangers. If you have been injured by a generic drug, it is important to talk to your lawyer about how this ruling may affect your rights to justice.

Beasley Allen Law Firm is currently investigating cases of women who have suffered blood clots, heart attacks, strokes or gallbladder damage after using any drospirenone-containing birth control pill.

Source: WebMD

SOURCE: Yaz Lawsuit › Generic versions of Yaz, Yasmin just as dangerous as brand name pills

By all accounts, Tania, who was studying to be a teacher, was the picture of health. She is now a statistic – a piece of data culled from research studies into the safety of birth control pills, like Yasmin, that contain the hormone drospirenone.

Yasmin is one of a family of birth control pills sold by Bayer. Other oral contraceptives that contain drospirenone include Yaz, Beyaz, and Safyral. The family of pills was Bayer’s top selling drug in 2010.

All birth control pills carry a slight risk for blood clots, but a new study suggests that pills that contain drospirenone may put women at even greater risk. The news has led the Food and Drug Administration (FDA) and Health Canada to undergo a safety review on the pills.

The study is based on about 300,000 women in the United Kingdom. Researchers found that women who were taking pills containing drospirenone were at about three times greater risk of developing blood clots in the lungs or legs than women taking oral contraceptives with an older hormone. Blood clots can cause heart attacks, strokes, and sudden death.

Bayer refuses to admit that its pills are more dangerous than others. The drug company also says its safety labeling includes a warning for blood clots. Genevieve finds this warning inadequate. “In the packet for Yasmin there’s a little booklet and it has 35 pages and on page 19 it lists the major side effects. I don’t believe Tania read it and I certainly didn’t. Because the pill is so widely accepted, you just don’t think that something might happen.”

Source: ABC

SOURCE: Yaz Lawsuit › Yasmin birth control pills claim another young life

The girl was prescribed Yasmin, manufactured by Bayer,  when she was 13 by her dermatologist to help clear up her acne. Her prescription was later changed to the generic Ocella, also manufactured by Bayer but marketed by Teva Pharmaceuticals. Yasmin and Ocella are part of a family of birth control pills that contain the hormone drospirenone. Other brands include Yaz, Yasminella, and Beyaz. Only Yaz and its generic equivalent Gianvi are FDA-approved for the treatment of acne in girls 14 and older.

The lawsuit alleges that Bayer heavily marketed the drugs to appeal to young women by highlighting its pills as a treatment for acne, and by downplaying the serious risks associated with the drugs.

All birth control pills carry a slight risk for blood clots, but recent studies suggest the risk with drospirenone-containing pills is even greater. Blood clots can cause strokes, heart attacks and sudden death. Pills containing drospirenone have also been linked to gallbladder damage.

Bayer faces about 7,000 lawsuits filed on behalf of women who allege they were not adequately warned that taking the pills could seriously injure or kill them.

SOURCE: Yaz Lawsuit › Family of deceased 15-year-old girl files Yasmin lawsuit

All birth control pills carry a slight risk for blood clots, but critics have long argued that Yaz and Yasmin put women at even greater risk. Both Yaz and Yasmin are made by Bayer Healthcare and contain the hormone drospirenone.

Health Canada’s announcement comes just days after the U.S. Food and Drug Administration (FDA) said it was keeping a watchful eye on two recent studies published in the British Medical Journal that compared the blood clot risks with drospirenone-containing birth control pills to pills that contained another popular birth control hormone known as levonorgestrel.

Birth control pills that contain drospirenone include Bayer’s Yaz, Yasmin, Beyaz and Safyral, as well as generics Ocella, Gianvi, Loryna, Syeda, and Zarah. Bayer has maintained that its pills are no more dangerous than other birth control pills; however, the pharmaceutical company faces thousands of lawsuits from women or their families who say that their drospirenone-containing pills caused them serious injuries such as blood clots, strokes, heart attacks, gallbladder damage, and even death.

Both Health Canada and the FDA say they will review all available information to fully assess the risk of blood clots with drospirenone-containing pills and will take appropriate action as necessary once the review is complete.

Sources:
680 News
FDA

SOURCE: Yaz Lawsuit › Health Canada reviewing data linking Yaz to greater risk of blood clots

The studies referenced by the FDA looked at VTE rates in women using birth control pills containing drospirenone compared with women taking pills containing levonorgestrel. Data showed that the risk for venous thromboembolism, or pulmonary embolism, is as much as two to three times greater with drospirenone-containing pills than with levonorgestrel-containing pills.

Bayer launched its blockbuster birth control pill Yaz with a huge marketing campaign that claimed it could conquer symptoms of premenstrual syndrome and clear up acne. The FDA fined Bayer for overstating the benefits of the drug and downplaying the risks, including the risk for blood clots.

Women began asking their doctors for Yaz by name, making it the most prescribed birth control pill in the country. The success of Yaz was only slightly hampered by a series of ads Bayer was forced by the FDA to run that clearly stated the risks associated with the pill. It wasn’t until reports of deaths and serious injuries in women who used Yaz that the public began to take notice.

Bayer has defended its oral contraceptives, arguing they are no more dangerous than other birth control pills. The new studies suggest otherwise. Bayer now faces thousands of lawsuits from women and their families who say they were not adequately warned of the risks associated with the pills, including blood clots (including VTE), heart attacks, strokes and sudden death.

The FDA recommends women who have questions about their oral contraception contact their doctors. If they experience any of the following symptoms of VTE to seek medical help immediately – persistent leg pain, severe chest pain, sudden shortness of breath.

Women who smoke and are older than 35 years of age should not take combination birth control pills because they increase the risk of serious cardiovascular events, including blood clots.

Source: FDA

SOURCE: Yaz Lawsuit › FDA warns of elevated blood clot risk in Yaz birth control pills

It’s time women put the burden of contraception on the men.

A team of Indian scientists is working to do just that – develop a birth control method for men. This experimental contraceptive is reversible and far less invasive than a vasectomy. It works by inhibiting sperm with a tiny electrically charged polymer inserted into a man’s testicles. When negatively charged sperm pass by the polymer, their cell membranes rupture and the tails are damaged. This cripples the sperm and leaves them unable to fertilize. The device reportedly does not inhibit libido nor does it diminish sperm count.

The device is still in the testing phases and effectiveness is still being determined. Researchers will also have to gauge whether the device is linked to any unwanted pregnancies or birth defects. At the very least, it offers a new alternative for men who are willing to step up and take responsibility for quelling unwanted pregnancies.

SOURCE: Yaz Lawsuit › Scientists working on birth control device for men

A Swiss appeals court has recently rejected Bayer’s request to punish a Swiss television station that reported there were about 190 deaths associated with Yaz and Yasmin in the Food and Drug Administration (FDA) database of adverse reactions. The database includes both confirmed and unconfirmed drug reports, and Bayer argued that it was not a true indicator of how dangerous the drug really is.

Yet, thousands of lawsuits levied against Bayer by women and their family members injured or killed after using the pills speak otherwise.

All birth control pills carry a risk for blood clots, but lawsuits contend that Yaz and Yasmin, both of which contain the hormones ethinyl estradiol and drospirenone, put women at even greater risk for blood clots. The disorder can lead to heart attacks, strokes and sudden death. Some lawsuits allege that Yaz and Yasmin also can damage the gallbladder, requiring surgery. Bayer faces more than 2,000 lawsuits over injuries and deaths caused by Yaz and Yasmin.

Bayer remains unwavering in its defense of its popular oral contraceptives. While the pharmaceutical company can’t fight the claims made in the U.S., it recently took on Swiss TV, alleging that the station’s report on deaths associated with the pills were “manipulative” and by reporting the story the station breached its “statutory requirement of factual accuracy.” Bayer first lost a ruling in lower court and earlier this month lost an appeal to a Swiss federal court on the basis that while the news story contained critical viewpoints, those views were correctly identified as such.

SOURCE: Yaz Lawsuit › Bayer loses case to silence media reporting dangers of Yaz, Yasmin

Bayer

“Given the already large and robust scientific body of evidence, in Bayer’s opinion, these studies do not change the overall assessment about the safety of Bayer’s oral contraceptives,” the company said in a statement.

Yaz and Yasmin are considered “fourth generation” birth control pills and use the hormones ethinyl estradiol and drospirenone. Bayer heavily marketed the pills, even touting Yaz as a cure-all of sorts for bothersome PMS symptoms and acne. The Food and Drug Administration ordered Bayer to rerun the ads, toning down its PMS claims (the drug was approved to also help ease symptoms of the more serious premenstrual dysphoric disorder, PMDD, but not PMS) and specifically outlining the risks associated with the pills, including the risk for life threatening blood clots.

Bayer has since been slapped with lawsuits from women and their families who have suffered from blood clots, heart attacks, strokes, gallbladder damage, and even death after using the pills. Bayer has long argued that Yaz and Yasmin are no more dangerous than other birth control pills.

All oral contraceptives carry a risk for blood clots, and lawsuits have maintained that Bayer’s pills put women at even greater risk. Previous studies that suggested as much were dismissed by Bayer. But two new studies back up plaintiffs’ claims, showing women who took contraceptives with drospirenone had more than twice the risk of developing blood clots than women on a hormone used in older generation pills, levonorgestrel.

Bayer still refuses to accept the blame. According to its statement, “Bayer’s assessment, (of the studies) based on its review to date, is that the manner in which the authors applied the study methodology reported in these two publications show significant flaws and the databases used provide less reliable conclusions than are available from existing scientific evidence around the risk of developing venous thromboembolism (VTE), or blood clots, with combination oral contraceptives (COCs).”

SOURCE: Yaz Lawsuit › Bayer dismisses new studies showing higher blood clot risk with Yaz, Yasmin

Bayer

Levonorgestrel is a progestogen that is used in both combination hormone pills and progestogen-only formulations. It is known by the brand names Escapelle, Plan B, Levonelle, NorLevo, Postinor-2, i-pill, Next Choice, and 72-HOURS. It is also the active ingredient in the Mirena-brand intrauterine device (IUD).

Blood clots have always been a risk factor with birth control pills, but mounting lawsuits against Bayer argue that Bayer’s formulation of drospirenone and ethinyl estradiol in Yaz and Yasmin puts women at greater risk. The same formulation of hormones is also in the generic oral contraceptive Ocella, as well as Bayer’s newly introduced folic acid-fortified pills Bayaz and Safyral.

Researchers from the Boston Collaborative Drug Surveillance Program at Boston University School of Medicine studied about 900 women on birth control since 2002. The blood clot risk for women taking Yaz or Yasmin was 30.8 per 100,000 person-years. Women on pills containing levonorgestrel had a rate of only 12.5 per 100,000 person-years.

Most alarming, researchers also found that women younger than 30 who used Yaz or Yasmin were at even greater risk for blood clots than women on second-generation pills. These young women had an incidence rate of 24.8 per 100,000 compared to only 5.39 per 100,000 if they took pills containing levonorgestrel.

SOURCE: Yaz Lawsuit › Young women at even greater risk for blood clots with Yaz, Yasmin

Drospirenone is a hormone that works like a diuretic. It is used in combination with another hormone, ethinyl estradiol, in Bayer HealthCare’s Yaz and Yasmin. Bayer recently released Beyaz and Safyral, two more birth control pills identical to Yaz and Yasmin, respectively, but with added folate. There are also generic versions of Yaz and Yasmin available, such as Ocella.

Diuretics can cause significant problems with the gallbladder that in some cases can lead to gallbladder removal. Some studies suggest that drospirenone can also increase potassium levels in the blood and lead to hyperkalemia, a condition which causes heart rhythm disturbances that can cause blood clots and lead to sudden cardiac death, heart attacks, or strokes.

Bayer has long fought allegations that its popular birth control pills can put women’s lives at risk, but with more than 2,000 lawsuits filed against the company from women who say they were harmed by the pills, Bayer’s defense looks weak.

The new study was funded by the Fonds de la recherché en sante du Quebec, a government-financed research agency, and is in the current issue of the Canadian Medical Association Journal.

SOURCE: Yaz Lawsuit › Yaz, Yasmin puts women at greater risk for gallbladder damage

The interim data comes from a large, prospective, observational cohort safety study on the increased risk of venous thromboembolism (VTE), or blood clots, in women who use birth control pills. The study was funded by Bayer HealthCare Pharmaceuticals Inc., makers of Yaz, one of the most popular brands of birth control pills.

Blood clots are a potential side effect for women who use combination birth control pills. But Bayer’s Yaz and its sister pill, Yasmin, have come under fire in recent years for advertisements that the Food and Drug Administration (FDA) said overstated the drug’s benefits and downplayed its risks.

Those criticisms were compounded when the pharmaceutical company was later hit by thousands of lawsuits from women or their family members who claimed that Yaz and Yasmin put them at even greater risk for serious health problems including blood clots, heart attacks, strokes, gallbladder damage, and even death. The lawsuits claim Bayer never fully warned women that using Yaz and Yasmin could potentially kill them.

Bayer has been quick to dismiss the charges against it, arguing that Yaz and Yasmin are no more dangerous than other birth control pills, calling blood clots a “well-established risk in women who use combination oral contraceptives (COCs).’” Bayer says it was important for the company to take a lead in the studying and communicating of the risks and benefits of combination birth control pills.

“The new information is helpful because while healthcare providers have long known about the risk of VTE associated with COCs, there was little information to indicate that there was an increased risk in women restarting COCs after a four week or greater period of non-use. This new information should provide both healthcare providers and women who choose a COC for contraception with additional information when making the decision to implement a pause in their COC routine,” said Leo Plouffe, MD, Vice President, US Medical Affairs, Women’s Healthcare, Bayer HealthCare Pharmaceuticals.

SOURCE: Yaz Lawsuit › Women more at risk of blood clots during first six months on ‘The Pill’

The data involved more than 3 million women from 2002 to 2009. The women ranged in age from 13 to 33 with at least six months of enrollment in insurance and prescription drug coverage. The study found that 18 percent of teenage girls ages 13 to 18 filled prescriptions for birth control pills in 2009, up year after year since 2002. This was a 50 percent increase among commercially insured teenagers and a 29 percent increase among teenagers on Medicaid. The No. 1 choice in birth control pills among teenaged women was Yaz.

When Yaz was first approved for marketing in the United States it was touted as more than for pregnancy prevention. Bayer’s ads said the oral contraceptive could quell irritability caused by premenstrual syndrome (PMS) and manage breakouts of acne. It wasn’t long before women began asking for the pill by name, and it became the top selling birth control pill in America.

But the Food and Drug Administration (FDA) soon caught wind of those ads, and ordered Bayer to run a series of commercials to clarify that the pill was not approved for PMS, but for the more serious premenstrual dysphoric disorder, or PMDD. Bayer was also told to clearly state the risks associated with the drug, including the risk for blood clots, heart attacks, strokes and gallbladder damage.

While all birth control pills carry a risk for blood clots, studies began to suggest that Yaz, a combination of ethinyl estradiol and drospirenone, put women at an even greater risk for the serious side effects. As a result, thousands of women and their loved ones have filed lawsuits against Bayer arguing they were not warned of the dangerous and life-threatening risks associated with Yaz.

SOURCE: Yaz Lawsuit › Yaz is most popular birth control pill among teenagers

About 7,000 lawsuits have been filed against Bayer by women or their family members who allege that they were not warned by Bayer that company’s birth control pills Yaz and Yasmin could put them at serious risk of life-threatening blood clots, heart attacks, strokes, and gallbladder damage. More plaintiffs are joining the lawsuit and some estimate that there could be as many as 14,000 plaintiffs in all.

While the documents are stored at a St. Louis-based law firm and are managed by one attorney with a full-time IT employee for technical support, firms across the country are helping review the documents and can access the database remotely. To date, about 150 attorneys have been trained how to use the data base, and up to 50 people review the documents as much as five days a week.

The paperwork not only includes documents related to Bayer’s Yaz and Yasmin, but also to generic versions of the drugs, including Ocella and Gianvi.

The first bellwether case trial is set for September. Aside from the federal litigation in southern Illinois, consolidated lawsuits are pending in Pennsylvania, California and New Jersey state courts.

SOURCE: Yaz Lawsuit › Bayer generates millions of pages for Yaz, Yasmin lawsuits

Yasmin is part of Bayer’s “four sisters” of oral contraceptives that include Yaz and Yasmin as well as the recently introduced folic acid-fortified pills Beyaz and Safyral. All four use a combination of the hormones ethinyl estradiol and drospirenone. The pills brought in more than $1.5 billion, a 13 percent drop from 2009.

Yaz was approved by the Food and Drug Administration (FDA) in 2006, and was marketed as a new kind of birth control pill that not only prevented pregnancy but also tackled PMS symptoms such as irritability and helped clear up acne. The marketing campaign launched Yaz into the best-seller category among birth control pills, with many women asking their doctors for it by name.

The FDA soon penalized Bayer for running ads that overstated the drug’s benefits and downplayed the serious risks, including the risk of blood clots, heart attack and strokes. The FDA also ordered the drug company to run a series of clarification ads.

Soon after, Bayer was hit with thousands of lawsuits from women who claim they suffered serious health problems from the pills and that Bayer knew the risks but did not adequately warn consumers.

The bad press surrounding Yaz and Yasmin have contributed to the drugs’ lagging sales over the past year, which may explain why the company is fighting generic competition that would devour more of its waning profits.

SOURCE: Yaz Lawsuit › UK blocks sales of generic Yasmin

Blood clots can occur after some surgeries, when people travel long distances, or sit in cramped positions for long periods of time. It can also be caused by medications, especially birth control pills. Some oral contraceptives may carry a greater risk for blood clots. For example, Bayer, maker of the popular birth control pill Yaz, is facing more than 2,000 lawsuits from women who say the pills caused them to suffer blood clots that in some cases led to serious complications such as pulmonary embolism, heart attack and stroke.

At least 100,000 cases of pulmonary embolism occur in the United States each year, and it is the third most common cause of death in hospitalized patients. If left untreated, about one-third of victims die, which is why the National Heart Lung and Blood Institute urges the public to know the symptoms of pulmonary embolism. The most common ones include shortness of breath when not exerting yourself, chest pain and coughing up blood.

Often, the only symptoms are those associated with DVT, such as swelling of the leg or along the vein of the leg, pain or tenderness in the leg, a feeling of increased warmth in the area of the leg that is swollen and tender, and red or discolored skin on the affected leg. Other symptoms include excessive sweating, clammy or bluish skin, light-headedness, fast or irregular heartbeat, and weak pulse.

These symptoms should be considered serious, and anyone who experiences these should seek medical attention immediately.

SOURCE: Yaz Lawsuit › Tennis star’s blood clot scare helps raise awareness

Most women who become pregnant are typically tested for gestational diabetes by their obstetricians. It is caused by high blood sugar (glucose) levels. Most women with gestational diabetes are able to control their blood sugar and avoid harm to themselves or their baby. Once the baby is delivered, the mother’s blood sugar usually goes back to normal. But these women are at risk for developing type 2 diabetes within five to 10 years of delivery. The new study suggests these women are at an even greater risk if they take the mini pill following pregnancy.

On a more positive note, another recent study found that women on mini-pills are at no greater risk for developing heart disease compared to women who were not taking oral contraceptives. The mini pills are also less likely to cause blood clots than the traditional estrogen-plus-progestin pills.

Some studies suggest that specific types of combination birth control pills, such as Yaz, which combines ethinyl estradiol and drospirenone, put women at an even greater risk for blood clots. To date, more than 2,000 lawsuits have been filed against Bayer, the makers of Yaz, from women who say they suffered heart attacks, strokes, blood clots and even gallbladder damage after taking Yaz.

SOURCE: Yaz Lawsuit › Mini pills may increase chances of developing type 2 diabetes

Generic drugs must still be approved by the FDA but the process is different than with brand-name medications. Emoquette was approved through the agency’s abbreviated new drug application process, which requires drug makers prove their drug is comparable to an approved medication in dosage, route of administration, quality, performance and intended use.

Drugs are not allowed to be marketed and sold in the United States without FDA approval. This process requires proof from clinical trials the medication is both safe and effective. But the FDA’s seal doesn’t guarantee there will be no problems.

In the early 2000s, the FDA approved Bayer’s Yaz birth control pills. The pills combined the hormones ethinyl estradiol and drospirenone, which also works as a diuretic. Bayer launched a massive marketing campaign that sent sales of Yaz skyrocketing.

It wasn’t long, however, before reports of blood clots, heart attacks, and strokes in young women taking Yaz began to surface. While oral contraceptives carry a risk for blood clots, the problem seemed to more often affect women taking Yaz. As lawsuits against Bayer began to mount, the pharmaceutical company responded by seeking – and obtaining – FDA approval for three more birth control pills with the same hormone combination as Yaz – Yasmin, Beyaz and Safyral.

SOURCE: Yaz Lawsuit › FDA approves generic birth control pill

The FDA does not regulate over-the-counter medications as it does prescription drugs, which raises safety concerns first and foremost. Birth control pills already carry risks that women should be aware of, including the formation of  blood clots. Women who smoke and those with a family history of blood clots are at an even greater risk for developing blood clots, which can lead to life threatening conditions such as heart attacks, strokes and pulmonary emboli.

There is also no word on which pills would be made available without prescription. Pills offer a variety of single or combination hormone options, and some even include diuretics or are fortified with vitamins. Some may put women at even greater risk for serious side effects, such as the blockbuster birth control Yaz, manufactured by Bayer. The company is currently facing more than 2,000 lawsuits from women who claim they were injured by Yaz.

The FDA says one of the biggest benefits to keeping oral contraception a prescribed product is that for many women getting a birth control prescription is the motivating factor in getting them to the doctor for their annual exam. If birth control pills suddenly became available over-the-counter, many woman may forego seeing their doctors altogether.

SOURCE: Yaz Lawsuit › DC considers making birth control pills available OTC

Two years later her doctor made a connection. Lana had been taking Yaz or Yasmin birth control pills for seven years, since 2001. The pills have been linked to gallbladder damage, yet Lana says she was never warned of those risks by the pills’ manufacturer, Bayer Corp. Lana is now one of more than 2,000 women who have filed lawsuits against Bayer. The plaintiffs claim that Bayer was fully aware of the risks associated with use of the pills, yet the company did nothing to warn users.

Yaz and Yasmin are known as fourth generation birth control pills. They contain the hormones ethinyl estradiol and drospirenone. Drospirenone also works as a diuretic, which can cause an increase in potassium levels in the blood and lead to hyperkalemia, which can cause heart rhythm abnormalities that can cause life threatening blood clots.

Lana is no longer taking the pills, but she still experiences problems and was diagnosed with post-cholecystectomy syndrome. The condition causes persistent pain I the upper right abdomen, nausea, vomiting, gas, bloating and diarrhea. Symptoms of the syndrome occur in about 5 to 40 percent of patients who undergo cholecystectomy.

Lana’s lawsuit seeks unspecified damages. The case has been assigned to Galveston County Court in Texas.

SOURCE: Yaz Lawsuit › Woman blames gallbladder problems on Yaz, Yasmin

The study, published in the Journal of Clinical Endocrinology and Metabolism, included data from more than 1,800 women between the ages of 16 and 44 on birth control pills and summarizes six previous studies related to heart attack risk in women taking the so-called mini-pills. Brand name mini-pills include Micronor and Ovrette.

More women take the combined estrogen-and-progestin pills than the mini-pills, and that is where researchers say the results become more skewed. The combined pills carry an increased risk for blood clots, which can lead to heart attacks, strokes, pulmonary embolism (blood clot in the lungs), and deep vein thrombosis, all of which can be life threatening.

Some studies suggest that some varieties of combined oral contraceptives put women at greater risk for blood clots, such as Yaz, a fourth-generation pill that includes the hormones ethinyl estradiol and drospirenone.

Women who are high risk for heart disease, such as women who smoke or have high blood pressure or a family history of blood clots, may consider switching to progestin-only products, or going off birth control pills altogether.

SOURCE: Yaz Lawsuit › Mini-pill may be safer than combination birth control pills

Yaz was marketed heavily across the globe, making it one of the best selling birth control pills and earning it more than $600 in sales in 2008. It is a combination of the hormones drospirenone and ethinyl estradiol. Drospirenone also works as a diuretic. Yaz is also touted as a treatment for acne and PMDD.

Bayer also sells Yasmin, a birth control pill with the same combined hormones but in different doses.

In 2010, Bayer also launched two other oral contraceptives with the same formulation but with added folic acid, known by the brand names Beyaz and Safyral. All four pills are considered to have the same side effects.

Despite the mounting lawsuits, Bayer stands by its defense that Yaz and its sister pills are no more dangerous than other birth control pills. The women who have filed lawsuits against Bayer say that the notion that Yaz is safe is simply a hard pill to swallow.

SOURCE: Yaz Lawsuit › Blood clots a serious side effect of Yaz birth control pills

Let’s take a closer look at these “four sisters” of Bayer oral contraceptives:

• Yaz is a combination birth control pill containing the hormones drospirenone (3 mg) and ethinyl estradiol (20 mcg). Drospirenone also works as a diuretic. It was the first birth control pill approved to treat premenstrual dysphoric disorder (PMDD), a condition with severe emotional and physical premenstrual symptoms. It is also used to treat moderate acne.
• Yasmin is a similar formulation as Yaz but contains 3 mg drospirenone and 30 mcg of ethinyl estradiol. Yasmin is only approved for the prevention of pregnancy and not for treating the symptoms of PMDD nor the treatment of moderate acne.
• Beyaz was approved for sale in the United States in September 2010 and is essentially identical to Yaz but was the first birth control pill to include folic acid. Folic acid is the B vitamin that has been shown in pregnant women to reduce the occurrence of brain and spinal cord defects in their children if taken before and during the first three months of pregnancy. Like Yaz, Beyaz is approved for use as a form of birth control, for the treatment of PMDD symptoms, and for the treatment of moderate acne.
• Safyral is Bayer’s folate-added version of Yasmin. Formulated with the same types and doses of active ingredients as Yasmin, Safyral also adds folic acid as an added benefit.

All four Bayer birth control pills are surprisingly similar and, like Yaz, carry the same risk of serious health problems. While all oral contraceptives carry a risk of blood clots, heart attacks and strokes, some say Bayer’s pills put users at greater risk than other pills. An unusually large number of women who take Bayer’s pills have also reported gallbladder damage that in many cases has resulted in surgery to remove the gallbladder.

SOURCE: Yaz Lawsuit › Bayer’s ‘four sisters’ of birth control pills have same bad reputation

Birth control pills contain a combination of estrogen and progestin, which can trigger clotting in the blood and lead to strokes, heart attacks and blood clots. Yaz and similar Bayer pills (Yasmin, Beyaz, Natazia, Angeliq and Teva’s Ocella generic) also contain drospirenone, a diuretic, that some say can cause an increase in potassium levels in the blood and lead to hyperkalemia, which causes heart rhythm disturbances that can cause blood clots and lead to sudden cardiac death or pulmonary embolism or strokes. Diuretics have also been associated with gallbladder problems.

Claims of venus thromboembolisms (including pulmonary embolisms and deep vein thromboses) make up 40-41 percent of the lawsuits, and strokes and heart attacks make up 9-10 percent of the claims. The remaining 43 percent involve gallbladder injuries, a problem not typically associated with blood clotting, nor with oral contraceptives. But few can deny the fact that numerous young women and teenagers taking Yaz have suffered from gallbladder problems, a condition that usually affects women in their 40s.

The first lawsuits against Bayer are scheduled to face juries in September 2011. Meanwhile, Bayer is fighting back with denials as well as a lineup of new similar birth control pills such as Natazia, Angeliq and Beyaz.

SOURCE: Yaz Lawsuit › Gallbladder damage most reported problem with Yaz birth control pill

Apparently, some lessons are never learned. The company has just agreed to pay another $3.3 million to Oregon, California and Illinois over ads for its vitamin One A Day Men’s Health Formula, that claim the supplement contains an ingredient that may reduce the risk of prostate cancer.

Bayer launched a “Strike Out Prostate Cancer” campaign with Major League Baseball and placed messages on its One A Day vitamins that read: “Did you know that prostate cancer is the most frequently diagnosed cancer in men and that emerging research suggests Selenium may reduce the risk of prostate cancer?” At issue is a federally funded Selenium study that found that selenium did not prevent prostate cancer in a group of otherwise healthy men, and if anything, Selenium may raise the risk of diabetes.

The study prompted the advocacy group Center for Science in the Public Interest to send a letter to Bayer asking them to stop making the false claims. Bayer did so but the group joined forces with the states and filed suit against the drug maker. The settlement requires Bayer to support future claims with “competent and reliable evidence.”

Meanwhile, supplement makers recently won a federal court ruling that allows a very qualified claim of a beneficial effect of Selenium on prostate cancer. That ruling may be appealed. As the Food and Drug Administration and the Federal Trade Commission argue over how to regulate claims made by supplement makers, consumers are left to wonder who they can trust.

SOURCE: Yaz Lawsuit › Questionable ads from Bayer make consumers wonder what to believe

But folic acid also offered other benefits, some experts claimed. Since folic acid lowers blood levels of the protein homocystine, which is linked to heart and blood vessel disease and other medical problems, some scientists suggested that the B vitamin could also lower the risk of heart disease, stroke or cancer.

However,  a new study published in the Oct. 11 issue of the Archives of Internal Medicine shows that even taken at high doses, folic acid supplements do not improve one’s risk of getting heart disease, a stroke or cancer.

To further complicate matters for Beyaz, the pill contains the same active ingredients as its sister product, Yaz – a hormone and a diuretic. Thus, Beyaz, like Yaz, is indicated not only for pregnancy prevention but also for the treatment of premenstrual dysphoric disorder (PMDD) and moderate acne. It also carries the same health risks, according to clinical studies conducted by Bayer.

Bayer contends that Yaz is no more harmful to women than other birth control pills, which carry a risk of life threatening blood clots. But more than 2,000 lawsuits by women who were seriously injured by Yaz beg to differ.

B vitamin-fortified or not, is Beyaz really a safe choice for women?

SOURCE: Yaz Lawsuit › New birth control pill contains folic acid, but is the B vitamin ‘all that’?

Yasmin and Yaz generate nearly $2 billion each year for Bayer, making the oral contraceptives the largest source of income for the drug company. The drugs contain a special formulation of hormones plus drospirenone, a diuretic, and were heavily marketed following FDA approval for not only preventing pregnancies but also relieving the severe emotional and physical symptoms of premenstrual dysphoric disorder (PMDD) and treating moderate acne.

As sales for the birth control pills exploded in the United States, reports began surfacing of serious side effects associated with the drugs, including heart attacks, strokes, blood clots and even gallbladder problems. Lawsuits followed, alleging the drug company was aware the pills put women at greater risk of life threatening health problems but failed to adequately warn consumers. Bayer claims its pills are no more dangerous than other birth control pills. More than 2,000 lawsuits have been filed against Yaz and Yasmin.

Earlier this month, the FDA approved Watson’s oral contraceptive Zarah, a generic version of Yasmin. Bayer also launched a variation of Yaz, called Beyaz, from which the company expects to generate an annual income of about $680 million.

SOURCE: Yaz Lawsuit › Bayer continues to fight generic competition of its birth control pills

Levomefolate calcium is a folic acid, the B vitamin recommended for all women of childbearing age because low folate levels are associated with neural tube defects such as spina bifida. Like Yaz, Beyaz is indicated for the prevention of pregnancy but can also be used to treat the symptoms of premenstrual dysphoric disorder (PMDD) and moderate acne. Beyaz’s added benefit is that it can help prevent neural tube defects in the offspring of women who conceive while using the pill or shortly after discontinuing it.

The launch of Beyaz comes at a critical time for Bayer, as the drug company faces more than 2,000 lawsuits from women who claim they were made sick by Yaz or Yasmin. The plaintiffs claim they suffered strokes, heart attacks, blood clots and even gallbladder problems after taking the pills but were not adequately warned by Bayer that taking the drugs could cause them serious health problems and even death. Bayer has held firm to its claim that Yaz is no more dangerous than other birth control pills.

An FDA press release said clinical trials with Beyaz showed the same overall safety profile as seen with Yaz.

SOURCE: Yaz Lawsuit › Bayer launches new birth control pill fortified with folic acid

There are more than 2,000 women across the country who would tell Beth to get off the pills immediately. The women, like Gina Miller, suffered serious health problems such as heart attacks, strokes, blood clots and gallbladder problems after taking Yasmin and its similar oral contraceptive, Yaz. They have now filed suit against Bayer, makers of Yasmin and Yaz, claiming they were not adequately warned that the birth control pills they were taking could cause life-threatening health problems and death.

Bayer has done little to reassure women, arguing its pills are no more dangerous than other birth control pills. Some studies, however, suggest that there is a higher incidence of adverse events with Yasmin and Yaz than other oral contraceptives. The pills, and their generic equivalents, are the only ones sold in the U.S. that contain drospirenone, a diuretic, that can cause an increase in potassium levels in the blood, which can lead to heart rhythm disturbances that can cause blood clots and lead to sudden cardiac death, pulmonary embolism, DVT and other serious problems.

Doctors caution patients not to suddenly stop taking any medications, including birth control pills. However, the serious side effects associated with Yasmin would suggest women like Beth should definitely talk to their doctor as soon as possible about how to safely make a switch.

SOURCE: Yaz Lawsuit › ‘Should I still be on Yasmin?’

Watson Pharmaceuticals

Like Yasmin, Zarah is a combination of the diuretic drospirenone and the hormone ethinyl estradiol. While all birth control pills carry risks of blood clots and other serious injuries, some studies suggest that Yasmin and its sister contraceptive, Bayer’s Yaz, carry a greater risk than other pills. To date, more than 2,000 lawsuits have been filed against Bayer from women who claim they were harmed but not adequately warned by the drug company that by taking the pills they would be at greater risk of life threatening blood clots, strokes, heart attacks and even gallbladder problems.

The lawsuits don’t seem to sway drug makers from moving forward with generic versions of Yaz and Yasmin. Watson, too, is facing a lawsuit from Bayer, which claims  Zarah infringes on Bayer’s patent for Yasmin. The case is currently pending in the U.S. District Court for the Southern District of New York. Despite the lawsuit, Watson has begun shipping Zarah for distribution.

SOURCE: Yaz Lawsuit › Watson receives FDA approval for Zarah, generic version of Yasmin

Novartis isn’t the only drug company to delve into web advertising. Last year, FDA’s Division of Drug Marketing, Advertising and Communications sent notices to 14 major pharmaceutical manufacturers informing them that their sponsored link advertisements violated disclosure agreements and did not adequately warn consumers of the drugs’ risks. This prompted Google to produce “FDA Friendly” banner ads, which were used by Bayer to market its blockbuster birth control pill Yaz. The ads’ headlines link to the product’s site, but the text encourages viewers to read the product information including the boxed warning.

Bayer is required to be extra cautious with its advertising of Yaz. The company launched its birth control pill with an advertising campaign that the FDA later said was misleading. The agency accused the company of overstating the drug’s benefits and using busy images to clutter its message on drug risks. Bayer was fined and ordered to run new ads that clearly stated the drug’s risks, which include blood clots, heart attacks, strokes, and gallbladder problems.

SOURCE: Yaz Lawsuit › FDA cracks down on drug companies’ use of web marketing

Despite a court order for the pharmaceutical company to hand over some 10 million pages of documents related to the oral contraceptive and the marketing for it, Bayer is playing hardball. The company is reportedly delivering the documents out of order or without attachments as it issues statements to the media that Yaz and Yasmin are no more dangerous than other birth control pills.

Yet, if that were the case, why did Bayer promote its oral contraceptives with flashy ads that, the Food and Drug Administration (FDA) says, overstated the benefits of the pills and downplayed the risks? The federal agency fined Bayer and ordered the drug company to launch a second campaign that more clearly stated the approved uses for the pills and the risks associated with them.

It seems every week there is another news story about a woman who has died or suffered severe health consequences associated with use of Yaz and Yasmin. That, coupled with the arrival of generic competition from drug maker Teva, has resulted in a 15 percent drop of Yaz sales. One can only wonder how much the legal settlements with Yaz/Yasmin victims will cost Bayer.

SOURCE: Yaz Lawsuit › Lawsuits against Yaz, Yasmin double to 2,000

Sure, the pharmaceutical company sells the top selling birth control pills in the nation – Yaz and Yasmin. The pills have earned the company a reported $1.5 billion in 2009 alone. Both Yaz and Yasmin contain drospirenone, a diuretic, which no other brand of oral contraceptive has. This special formulation, Bayer says, makes the pills an effective treatment for premenstrual dysphoric disorder (PMDD) and moderate acne. The company launched an advertising campaign for Yaz in 2007 and 2008 that resulted in skyrocketing sales.

It wasn’t long before the Food and Drug Administration (FDA) found those ads to be misleading. The agency accused Bayer of exaggerating the pills’ benefits and camouflaging the risks behind busy graphics. In February 2009, Bayer agreed to spend $20 million to run a series of corrective ads. They also agreed to submit future ads for the pills to the FDA for approval. But the damage had already been done. Thousands of women began suffering from blood clots, heart attacks and strokes, and soon after began filing lawsuits against Bayer saying they were not adequately warned of the risks.

Now, Bayer wants to assure us that they are a trusted source for women with questions about their contraception. I think I’ll leave the medical advice to my physician instead.

SOURCE: Yaz Lawsuit › Should you really trust Bayer for contraception advice?

High blood pressure is known as the silent killer because most often there are no symptoms. The symptoms that do occur include chest pain, confusion, ear noise or buzzing, irregular heartbeat, nosebleed, tiredness, and vision changes. Complications from high blood pressure include aortic dissection, blood vessel damage, brain damage, congestive heart failure, kidney damage, kidney failure, heart attack, hypertensive heart disease, stroke and vision loss.

There are many different medications that are used to treat high blood pressure. You can lower your risk by making lifestyle changes, including exercising, losing weight and following a healthier diet. You may also be advised to stop taking other medications, such as birth control pills.

Oral contraceptives can increase blood pressure and carry a slight risk of blood clots that can lead to heart attacks and strokes as well as other life-threatening problems. Recent studies suggest that some pills are more dangerous than others, such as the country’s most popular birth control pill, Yaz, also known as Yasmin and by the generic ocella. Bayer, the maker of Yaz and Yasmin, currently faces more than 1,100 lawsuits from women who say the pills caused them to suffer from blood clots, heart attacks, strokes, gallbladder damage and other serious health problems.

SOURCE: Yaz Lawsuit › Women with high blood pressure should use caution with ‘the pill’

“Bayer is committed to vigorously enforcing its intellectual property and continues to pursue its patent infringement case filed earlier against Teva in Nevada,” Bayer said in a statement. The suit filed in Nevada asks for an injunction to prevent Teva from selling Gianvi. Teva was awarded a 180-day marketing exclusivity period for Gianvi by the Food and Drug Administration (FDA) after being the first company to file an Abbreviated New Drug Application (ANDA). Bayer says Teva is prematurely launching its new drug.

Bayer says it dropped its suit in Delaware because Nevada was a more appropriate venue. Concentrating its efforts in Nevada “will eliminate the risk of inconsistent adjudications,” Bayer said in a statement.

The fight between Bayer and Teva over their rival birth control pills has become heated over the past few weeks. Last month Bayer argued that Teva made claims on Gianvi’s safety label that were false. Gianvi’s label claimed that the pill contained the same technology as Yaz that would extend its shelf life. Teva has agreed to inform U.S. pharmacists on a weekly basis for three months about the corrected physician prescribing information on the label. The information has already been sent to the FDA for review and added to Teva’s website.

Bayer’s legal woes concerning Yaz are expected to continue for some time. The company faces more than 1,100 lawsuits from women who claim the popular birth control pill caused them to suffer from serious injuries such as blood clots, strokes, gallbladder problems, and even death.

SOURCE: Yaz Lawsuit › Bayer drops lawsuit against Teva over Yaz/Gianvi, but the fight continues

Stewart was prescribed Yaz by her gynecologist in September 2007 to treat cramps associated with her period. Yaz is marketed as a contraceptive that also treats premenstrual dysphoric disorder (PMDD), premenstrual syndrome, as well as moderate acne. It also is the only birth control pill to contain ethinyl estradiol and drospirenone, a diuretic.

In June 2008, Stewart began to feel pain in her abdomen and learned that her gallbladder was not functioning properly. Two months later her gallbladder was removed. Stewart took a short break from Yaz until April 2009, when she resumed treatment only to go off of it again when she says the pills made her feel queasy. Severe cramping a few months later led her to go back on Yaz. Within days of resuming treatment, Stewart’s lawsuit claims she began suffering severe depression and suicidal thoughts that led her to attempt suicide on two separate occasions.

Stewart’s lawsuit names Bayer, Bayer HealthCare Pharmaceuticals, Bayer HealthCare AG, Bayer HealthCare LLC, Bayer HealthCare Corporation, Berlex Inc., and Berlex Laboratories Inc. The plaintiff seeks unspecified damages, court costs, and attorney fees.

SOURCE: Yaz Lawsuit › Woman blames Yaz for gallbladder damage, severe depression

Now, Bayer has waged another fight against the rival drug company. Bayer filed suit against Teva claiming some information on Gianvi’s label was false. The drug’s safety label claimed the birth control pill contained the same technology as Yaz that extended its shelf life. According to Bayer, Teva will inform U.S. pharmacists on a weekly basis for three months about the corrected physician prescribing information on the label. Teva has already updated the information on its U.S. website and provided the Food and Drug Administration with the corrected information.

Yaz contains drospirenone and ethinyl estradiol that is enclosed within a beta-cyclodextrin (betadex) clathrate. A clathrate is a molecule that forms a “cage” around another molecule or molecules. The betadex clathrate in Yaz is a Bayer-patented technology that protects the enclosed ethinyl estradiol molecule and stabilizes the product against oxidation. This patented technology enhances the product’s shelf life.

Bayer also faces more than a thousand lawsuits from women who claim they have suffered serious injuries such as blood clots, strokes and gallbladder damage from Yaz but the drug’s safety label did not adequately warn them about the risks.

Yaz has earned Bayer more than $1.5 billion since 2009.

SOURCE: Yaz Lawsuit › Bayer, Teva rival birth control pills go head-to-head in court

Brenda’s story is told far too often these days. She is one of more than 1,100 women suing the drug company alleging claims of serious health problems after taking Yasmin, also known as Yaz. The lawsuits claim Bayer was aware of the increased risk of life-threatening blood clots in women taking Yasmin but they failed to adequately warn consumers of that risk. Some studies have backed up those claims; however, Bayer contends the blood clot risk for Yasmin and Yaz is no greater than other oral contraceptives.

Bayer has a reason to contest the claims made by the defendants. Its popular birth control pills have brought in $1.5 billion since 2009, making Yaz and Yasmin the most popular birth control pills in America and a favorite in Canada and numerous European countries. Yasmin and Yaz are different from other birth control pills because they contain drospirenone, a diuretic, that can increase potassium levels in the blood. This imbalance can trigger heart rhythm disturbances that can cause blood clots that can lead to pulmonary embolism, strokes, or even sudden cardiac death. The pills have also been linked to gallbladder disease.

Source: WPIX

SOURCE: Yaz Lawsuit › ‘Wicked’ understudy suffers stroke, joins lawsuit against Yasmin

Bayer has reason to want to protect its territory. Yaz, also known as Yasmin, brought in $782 million in sales in 2009, making it the top oral contraceptive in the nation. However, with popularity comes criticism. Bayer faces more than 1,100 lawsuits from women who allege that Yaz caused them to suffer serious health problems including heart attack, stroke, pulmonary embolism, blood clots, kidney failure, deep vein thrombosis, and gallbladder disease. Some fatalities have also been reported.

Yaz is marketed as an innovative new type of birth control pill containing drospirenone and ethinyl estradiol that not only serves as an effective contraceptive but also a proven treatment for premenstrual dysphoric disorder (PMDD) and severe acne. Drospirenone is a diuretic that can increase potassium levels in the blood and cause heart rhythm disturbances that can lead to blood clots and other serious problems.

The pills’ safety labels include a risk of potentially life threatening events, but women say Bayer downplayed those side effects even though it knew Yaz was just as, if not more, dangerous than other oral contraceptives. It is expected Gianvi will carry the same risks as its brand-name competitor.

Source: Globes

SOURCE: Yaz Lawsuit › Bayer sues Teva for prematurely marketing generic Yaz

Like Natazia, Yaz and Yasmin were considered a new type of birth control pill. Yaz was approved by the FDA in 2006; Yasmin was approved in 2001. Both pills combine ethinyl estradiol and drospirenone, a diuretic not found in any other birth control product. The pills are marketed for the added benefit of treating severe acne and premenstrual dysphoric disorder, or PMDD. Both Yaz and Yasmin soared to the top spot on Bayer’s pharmaceutical sales list, bringing it more than $600 million in 2008 alone. It seemed almost too good to be true.

Then came the reports of serious injuries in women who took Yaz and Yasmin. The diuretic was believed to raise the potassium in women’s blood to dangerous levels, causing blood clots to form. Serious adverse event reports began pouring in, including heart attack, cardiac arrhythmias, stroke, pulmonary embolism, kidney failure, seizures, deep vein thrombosis (DVT), gallbladder disease, hepatic adenomas and even sudden death. The company now faces hundreds of lawsuits from women who say they were not adequately warned by Bayer of the serious health risks with using Yaz or Yasmin.

Prior to approval, two studies were conducted on the effectiveness of Natazia with a sample of 1,867 women. The most common side effects reported were irregular bleeding, headaches, nausea and vomiting.

SOURCE: Yaz Lawsuit › Yaz, Yasmin makers get approval for new birth control pill

The biggest disappointment on Bayer’s books was a 10.2 percent decrease in profits from sales of its blockbuster oral contraceptive, Yaz, also known as Yasmin and Yasminelle. Sales of the birth control pill, which combines drospirenone and ethinyl estradiol, have suffered in the U.S., according to Bayer, because “the discussion surrounding the thrombosis risk of contraceptives containing drospirenone.” Bayer says that it continues to believe that the risk profile is comparable to that of other combinations and “Yaz and Yasmin remain good choices for contraception when used as directed.”

Bayer is facing hundreds of lawsuits in the U.S. and beyond, claiming the company didn’t adequately warn consumers of an increased risk of serious health problems including stroke, heart attack, gallbladder problems and blood clots associated with Yaz.

As a result of the company’s weak pharmaceutical line, Bayer has lowered its sales guidance for the health care unit for 2010 to 3 percent from 5 percent. According to Bayer chairman Werner Wenning, “we are optimistic about the future and intend to build on the positive developments prior to 2009.”

SOURCE: Yaz Lawsuit › Bayer’s drug sales suffer due to bad press on Yaz blood clot risk

Bayer Schering Pharma

“Yasmin’s positive benefit/risk profile remains unchanged. Our wealth of post-marketing safety data includes more than 42 million women with years of drospirenone use, as well as two epidemiological studies involving more than 120,000 oral contraceptive users. We are convinced that Yasmin is a good choice for women seeking convenient and reliable contraception if they use the product as directed. Bayer will continue to provide information which will support health care providers and their patients in taking informed decisions about appropriate treatment choices,” said Kemal Malik, MD, Chief Medical Officer at Bayer Schering Pharma, in a press release issued by the drug company.

The news is hardly reassuring for the hundreds of women who have been injured by Bayer’s Yasmin who have filed lawsuits in both the United States and Canada. They contend that flashy advertisements from the company downplayed the serious side effects of the drug, and that its formulation with the added diuretic made women more susceptible to suffering gallbladder problems, blood clots and other serious ailments. After strict orders and a stiff penalty by the Food and Drug Administration, Bayer has since bankrolled another advertising campaign aimed at clarifying its approved usages and explaining the serious side effects it may cause.

SOURCE: Yaz Lawsuit › Yasmin birth control pill to receive label changes

According to data collected by Kissela and presented at an American Stroke Association conference last month, in little more than a decade the percentage of people in the Ohio-Kentucky area age 20 to 45 having strokes has skyrocketed from 4.5 percent to 7.3 percent. Experts say they expect national statistics to mirror those in Ohio-Kentucky.

Kissela blames poor diets that spur obesity, diabetes and high blood pressure in younger individuals. But according to Diane Book, director of the stroke program at Froedtert Hospital in Wauwatosa, another risk factor is the prevalence of birth control pills. Data from the Centers for Disease Control and Prevention indicates that birth control pill use among females age 15 to 44 has increased from 27 percent in 1995 to 31 percent in 2002.

Oral contraceptives can significantly increase a woman’s risk of stroke by two to three times more than for women who do not take birth control pills. Makers of oral contraceptives are required by the Food and Drug Administration (FDA) to warn consumers of the increased risk of strokes and other health hazards from use of their products, but more than 1,100 women injured by birth control pills have filed lawsuits against Bayer, the makers of the blockbuster birth control pill Yaz, saying the company didn’t sufficiently warn them.

SOURCE: Yaz Lawsuit › Birth control pills contribute to more strokes among young women

Yaz, also known by the brand name Yasmin and the generic brand Ocella, is Bayer’s top-selling oral contraceptive and one of the most popular choices among women and doctors for birth control. Last year, the company raked in more than a billion dollars from the sale of Yaz. The pill is different from other birth control pills because it contains a diuretic, drospirenone, that can raise the potassium in blood to dangerous levels and cause to blood clots that can lead to sudden cardiac death, pulmonary embolism or strokes.

The lawsuits allege that Bayer didn’t do enough to warn women about the serious health risks to women who take Yaz. Even the Food and Drug Administration (FDA) cracked down on the drug company, saying advertisements for the birth control pill were overstating its benefits and understating the risks involved. Yaz commercials touted added benefits such as treatment for symptoms of premenstrual syndrome and acne. Since the FDA crackdown, Yaz was forced to run a series of ads clarifying the use of Yaz and clearly stating the dangers of taking the drug.

Victims say it’s too little, too late.

Bayer’s 2009 annual report does not specify how many women have died from the drug, but the FDA puts the count as high as 59.

SOURCE: Yaz Lawsuit › Bayer facing more than 1,100 lawsuits from women injured by Yaz

The Tennessee Tech student had been taking the drug for about six months when she suddenly passed out in the shower. Her roommate called 911, and when Leah briefly regained consciousness, her roommate got her mother, Traci, on the phone. “Leah told me that she was scared, and that she was tingling all over,” Traci tells WREG-TV. “I told her it was going to be OK, that me and daddy was coming.”

But they arrived too late. Leah died less than an hour after she collapsed. Doctors say what killed her was a blood clot in her lung, also known as a pulmonary embolism. “How does this happen to a healthy 20-year-old lady?” Traci asks. The answer may be in the birth control pill she was taking.

The diuretic drospirenone that is in Yaz can cause an increase in potassium levels in the blood, which can lead to hyperkalemia, a condition that causes heart rhythm disturbances that can cause blood clots that can trigger cardiac death or pulmonary embolism or strokes. Diuretics also can cause significant problems with the gallbladder, leading to gallbladder removal.

The Mayfields have joined at least 50 other women injured by Yaz and filed a lawsuit against Bayer. The lawsuit alleges that the drug maker ignored the increased risks of Yaz and kept it on the market to enjoy mounting profits. Now Traci wants to warn others of the dangers of Yaz.

“(Leah) didn’t have to die,” Traci says. “She didn’t have to die because of a pill.

SOURCE: Yaz Lawsuit › Mother warns others of the dangers of Yaz

What the Food and Drug Administration (FDA) wanted Bayer to clarify are what the agency considers misleading statements about the drug’s ability to improve women’s moods and clear up acne while downplaying the drug’s potential health risks. Yaz, also known as Yasmin or the generic Ocella, is currently being blamed for increasing women’s risk of serious adverse events such as heart attack, stroke, pulmonary embolism and death.

The warning the FDA issued to Bayer is one of 41 enforcement notices sent to drug companies by the agency’s Division of Drug Marketing, Advertising and Communication (DDMAC) in 2009. The company issued 21 in 2008. DDMAC head Thomas Abrams says the increased number of warning letters is a direct result of FDA chief Dr. Margaret Hamburg’s pledge to crack down on makers of drugs and medical devices for questionable promotional messages.

“We’re trying to get the point across to industry that we want them to comply with the law because it affects public health,” Abrams said. “If you don’t comply with the law, we are going to take action. We are not going to tolerate having consumers or health care professionals misled.”

As part of a settlement on the charges of deceptive consumer advertising, Bayer agreed to run the clarification ads, and for the next six years submit all ads for Yaz to the FDA for screening before they appear.

Sources:
New York Times
Reuters

SOURCE: Yaz Lawsuit › FDA cracks down on deceptive advertising of drugs

Yaz incorporates a unique progestin, drospirenone, with ethinyl estradiol, a more common ingredient used in birth control drugs. Many women who have been injured after starting a Yaz regimen allege that the drug poses a multitude of serious risks, which Bayer downplayed in its Yaz marketing campaigns.

The U.S. Food and Drug Administration admonished Bayer in October 2008, citing the company for “significant deviations” in its promotion of Yaz. The complaint largely centered on the understatement of the drug’s risks and the overstatement of its benefits, including the treatment of conditions for which the drug was not approved. The misleading marketing campaign is frequently cited in lawsuits brought against Bayer by former Yaz users.

Some of the most serious side effects associated with Yaz include stroke, heart arrhythmia cardiac arrest, deep vein thrombosis and other forms of blood clotting, pulmonary embolism, gallbladder disease, kidney damage or failure, and sudden death.

Judge Herndon told Southwestern Illinois’ Belleville News-Democrat that he may also conduct bellwether trials, a cluster of cases selected because they reflect the charges and allegations of the other lawsuits. The outcome of bellwether trials helps establish guidelines for other cases.

When a significant number of similar lawsuits, such as those being brought against Bayer over Yaz injuries, accumulate in federal courts, the Judicial Panel on Multidistrict Litigation normally moves to consolidate them in one U.S. District Court to avoid redundant efforts and inconsistent pre-trial rulings. The dynamics of these representative trials will then be considered in the evaluation of other cases.

SOURCE: Yaz Lawsuit › Southern Illinois district court to handle Yaz lawsuits

The plaintiff, who resides in Belpre, Ohio, had been taking Yaz for about a year when she developed deep vein thrombosis in her leg. She spent three days in the hospital, where like many other women who use Yaz, she was put on a regimen of blood thinners to dissolve the clot and reduce the swelling in her leg.

Deep vein thrombosis (DVT) is a very serious type of blood clot that can lead to serious complications and death if not treated properly. Clots that form a DVT can become dislodged, traveling through the bloodstream to the lungs and causing a pulmonary embolism, resulting in permanent damage to the lung. DVT can also cause stroke, cardiac arrest, and other potentially deadly conditions.

Yaz contains drospirenone, a synthetic progestin used in Yaz, Yasmin, and Ocella, which is a generic form of Yasmin. Drospirenone has been shown to increase potassium levels in some women who take the drug, which can lead to DVT and affect the function of several organs, including the heart.

The Ohio plaintiff’s lawsuit was filed in New Jersey Superior Court. The suit alleges that the plaintiff’s injuries were the result of Bayer’s failure to adequately warn consumers of the drug’s risks. Her attorney claims that Bayer knew Yaz to be more dangerous than other birth-control pills, but chose to downplay the drug’s hazards.

SOURCE: Yaz Lawsuit › Ohio mother sues Bayer, alleging Yaz caused blood clot

The plaintiff began taking Yaz after her gynecologist reassured her of the drug’s benefits and safety. After weeks of using Yaz, however, the woman began experiencing severe pain that sent her to the emergency room twice for general treatment and CT scans.

It took 13 hours for doctors to finally discover the problem. According to the Times, “In her left lung, the pulmonologist told her, was the largest blood clot they had ever seen and there were others in her right lung as well.”

The woman spent 6 days in the hospital as she was treated with 2 types of blood thinners to dissolve the clots in her lungs. Doctors expected a good recovery but told her that she might never be completely the same . Two weeks after the treatment, she told the Times that she is “incredibly tired most of the time.”

The plaintiff said that a couple of days after the treatment the severity of her situation suddenly hit her. “Wow, I almost died,” she told the Times. Now she strives to tell others about how Yaz affected her and has put the lives of so many other women in danger.

“It’s not just about women who are my age,” she told the Times, adding that lots of younger women are being seriously injured by the drug.

“There’s no reason for blood clots to be forming except for this pill and it’s a very scary situation,” she said.

Bayer has defended itself and Yaz against the allegations, pointing to the two Bayer-funded studies that showed the drug had a safety profile similar to other, more traditional oral contraceptives.

Another Yaz study, not funded by Bayer, found women who took Yaz to be more at risk for blood clots, heart attacks, and strokes. Those results were echoed by a more recent study published by the British Medical Journal in August.

SOURCE: Yaz Lawsuit › Recovering Maryland woman sues Bayer after Yaz nearly killed her

“She was short of breath. She was having severe chest pains and her face was changing colors,” Kraus told WTAE.

“She ended up going into cardiac arrest three times. One time it took 10 minutes to revive her. They eventually had to do emergency surgeries because they noticed there were two huge blood clots, one in each pulmonary artery,” Kraus said.

Kraus said that because of Yaz, her daughter now faces possibly lifelong struggles with pancreatitis, liver function problems, and acute kidney failure. Kraus and the other plaintiffs have requested a jury trial, more than $150,000 in compensation, attorney fees, court costs, and punitive damages.

Bayer Corporation, which is headquartered in Pittsburgh, defended itself from the allegations in a statement to WTAE.

“The complaints we have reviewed so far pertain to side effects that are warned about in the labeling of all contraceptives. Bayer will defend itself vigorously against these lawsuits,” a company spokesman said.

The lawsuit, however, alleges that Bayer grossly downplayed the risks of Yaz in its advertising campaigns and that the number of adverse events caused by Yaz is at least 10 times more than the number reported incidents, possibly 100 times more.

“I just don’t want anybody else to see their child go through anything like this ever again,” Kraus told WTAE.

Source: http://www.thepittsburghchannel.com/

SOURCE: Yaz Lawsuit › Mother says Yaz nearly killed her daughter

When customers go to Google’s search engine and perform a search for information on Yaz or “the pill,” they will see this simple new ad format appear in the search results. Some sponsored links will appear at the top of the results in a yellowish box. One of the links will lead to Bayer’s website for Yaz and will contain a gray-text notice: “Click to see full safety and prescribing information, including boxed warning.”

Why is Bayer using this new format for Yaz? Because the U.S. Food and Drug Administration has warned pharmaceutical companies about using the text promos for drug advertising since they do not contain any warnings or disclaimers to customers about possible side effects, health risks, and other drawbacks.

Bayer clashed with the FDA last year over its Yaz advertisements. The company aired a couple of television commercials titled “Not Gonna Take It” and “Balloons” that promoted the drug for unapproved uses, downplayed its risks and side effects, and used competing music and visual to draw the viewer’s attention away from the safety information. The FDA ordered the ads off the air and requested that Bayer spend a minimum of $20 million on a “corrective” ad campaign.

Other drug companies, anxious to promote their drugs through Google’s sponsored links without being called out by the FDA, will no doubt keep a watchful eye on the agency’s reaction to the new Yaz links.

SOURCE: Yaz Lawsuit › Bayer tests Google’s new ad format for Yaz promotion

Development of gall stones and gall bladder disease are among the serious risks associated with the oral contraceptive Yaz. The drug has also been blamed for elevating the risk of cardiac arrhythmias and heart attack, stroke, pulmonary embolism, blood clots, kidney failure, seizures, deep vein thrombosis, hepatic adenomas and sudden death.

According to the lawsuit, 50 deaths attributed to the use of Yaz and Yasmin were reported to the U.S. Food and Drug Administration between the first quarter of 2004 and the third quarter of 2008.

The lawsuit alleges that Bayer markets Yaz and Yasmin “as providing the same efficacy as other birth control pills in preventing pregnancy, but with additional benefits,” rather than the higher risks the drugs pose.

“The foreseeable risks of the product exceeded the benefits associated with its design or formulation. Or they were more dangerous than an ordinary consumer would expect,” the lawsuit states.

The plaintiff seeks compensatory and punitive damages, medical expenses and economic damages, and attorney’s fees. Because Bayer ran a deceptive ad campaign for Yaz, hailing the drug for uses unapproved by the FDA while downplaying its risks, the plaintiff also seeks an unspecified amount of punitive damages.

Source: http://www.chicagonow.com/

SOURCE: Yaz Lawsuit › Chicago woman sues Bayer over Yaz-related injuries

“Even though I’m old, I don’t want the horrifying side effects of aging to prevent me from doing what I love,” Haskins, who just turned 30, jokes. “I want to walk with canoes, peel oranges, play fetch with my pup, and do stuff with horses,” she says while a montage of images pulled from actual television drug ads plays. In one of the ads Haskins shows, anatomy takes the form of bouncing water balloons; in another, people are made of pipes. After all, cute, cartoon-like illustrations help lighten ads for drugs that pose very serious side effects for some people.

Amusing as Haskins’ Target episode is, it effectively illustrates just how outlandish and just plain silly some pharmaceutical advertising can be.

It’s also not the first time that Haskins has featured drug commercials on Target: Women. Last year, she spoofed big pharma television ads for birth control drugs, noting how they are touted as a way to have fewer periods more than anything else.

“Fewer periods! Yay! Now we don’t have to leave the tribe and go sit in that hut for a week. That was a bummer,” Haskins says.

Drugs developed for one thing but marketed as a treatment for something else is a common ruse employed by some pharmaceutical companies to make their products more enticing. Negative disclosures about the drugs, such as the legally required information about side effects, may be washed out with distracting music and visuals. That was how Bayer advertised Yaz last year, before the Food and Drug Administration cited the company for false and misleading advertising and ordered a redo.

“You may have seen some Yaz commercials recently that were not clear. The FDA wants us to correct a few points in those ads,” the presenter in the revised commercial says.

The Yaz advertisements spawned a number of video skits lampooning the drugmaker’s claims and the style in which they are presented: a group of girlfriends in a lively bar discussing side effects in a way that would never happen in real life. One woman, who says she “didn’t go to med school for nothing,” gives her friends an off the cuff and very clinical rundown of the drug’s risks while her friends listen intently.

Inserting herself into this scenario, Haskins asks “Does anyone think Stephanie is acting super weird right now?”

For all the risks attached to some blockbuster drugs, it’s good to see that the absurdity of drug advertising isn’t sliding by unnoticed.

SOURCE: Yaz Lawsuit › Comedian lampoons the absurdity of drug ads

The plaintiff claims that at the time, she was not aware the FDA had not approved Yaz for the treatment of skin conditions. In an extensive and aggressive marketing campaign, Bayer touted its birth control drug as an effective treatment for acne and symptoms associated with Premenstrual Syndrome (PMS) – conditions for which the FDA never tested or approved Yaz.

In October 2008, FDA officials warned Bayer that its Yaz ads intentionally mislead and confused viewers by overstating the drug’s effectiveness, overselling its benefits, and not adequately communicating the drug’s potential for serious side effects, including blood clots, cardiac arrest, and gallbladder disease. According to the FDA, the commercials used distracting visuals, multiple scene changes, and background music that effectively interfered with the audio presentation about the serious risks associated with the drug.

“Bayer promoted Yaz with the slogan ‘the difference a little chemistry can make,’” the plaintiff said. “What Bayer did not disclose was how negative that difference can be. Yaz gave me life-threatening injuries that have forever altered my life.”

After several months of Yaz therapy, the plaintiff developed an acute pain in her left shoulder and had difficulty breathing. A visit to the doctor revealed the plaintiff had developed blood clots in both her lungs. She was hospitalized immediately and treated successfully, but just one month later she developed gallstones and had to undergo surgery for their removal.

The plaintiff alleges that she “suffered months of anxiety and nausea related to (the) medical procedures and drugs given to treat the adverse side effects (she) developed from taking Yaz.”

The complaint charges that had Bayer properly warned patients about the dangers of using Yaz strictly as an acne treatment, the plaintiff could have avoided serious injury.

The lawsuit was filed in the Superior Court of New Jersey, where Bayer’s American operations are based. The plaintiff seeks an unspecified amount of compensatory damages.

SOURCE: Yaz Lawsuit › Injured by Yaz, SC nurse files lawsuit against Bayer

Pulmonary embolisms are blockages in one of the arteries leading to the lungs formed by a substance that has migrated through the bloodstream from another part of the body, commonly the legs. Clinical studies of Yaz conducted in Denmark and the Netherlands suggest a link between the Yaz ingredient drosperinone and a higher occurrence of blood clots than in women who took traditional contraceptives containing levonorgestrel.

A spokesperson for Bayer said that the company is cooperating with the investigation, but that it stood by the safety of its drug.

“A singular case, as tragic and sad as it is, does not indicate an increased risk for the whole group of women who take the pill,” Oliver Renner, a Bayer spokesman, told Bloomberg. “Studies have shown that the risk isn’t higher for Yaz than for other oral contraceptives.”

Of course, Bayer’s spokesperson dismisses the results of the two independent clinical trials and focuses on the more favorable outcome the Bayer-funded clinical test, which suggested the risks of Yaz were similar to those of traditional birth control therapies.

As the top selling oral contraceptive in the world, Yaz is big business for Bayer. The drug brought in $1.86 billion just in the first quarter of 2009.

SOURCE: Yaz Lawsuit › Switzerland investigates the death of young Yaz user

The New York Times recently published a report about the dangers frequently associated with Yaz and other oral contraceptives. The article observes that one Bayer-sponsored European study involving tens of thousands of women found no difference in the level of cardiovascular problems or death between women taking Yaz and women who took levonorgestrel, a much older progestin-based drug.

However, the results of two other studies conducted in Denmark and the Netherlands and published in the British Medical Journal last month, showed that women who took Yaz and other newer progestins had a higher risk of blood clots, which can adversely affect the heart.

One doctor quoted in the New York Times report theorized that Yaz and other newer forms of birth control may have a different affect in European populations versus the more racially diverse and genetically mixed American population.

However, Dr. Frits Rosendaal, a clinical epidemiologist at Leiden University Medical Center in the Netherlands, told the New York Times that patients taking Yaz should switch to birth control drugs containing levonorgestrel. “Even if the risk of thrombosis is low, why not choose the lowest risk, just in case?” he told the New York Times.

Both Bayer and the FDA are conducting ongoing studies designed to measure the safety risks of Yaz and Yasmin against drugs that do not contain drospirenone.

SOURCE: Yaz Lawsuit › Yaz health risks: better safe than sorry?

Earlier this year, the U.S. Food and Drug Administration sent a letter to Bayer Healthcare questioning the company’s ability to handle active pharmaceutical ingredients (API) testing. Bayer acknowledged the FDA’s concerns in an April response to the agency, but said that it had analyzed all relevant batches using its own testing standards and found that the quality of the U.S.-bound drugs was unaffected. Bayer stood by its quality control methods publicly as well.

Last month, the FDA sent another letter to Bayer, warning the company about “significant deviations” in its testing of key Yaz ingredients. “Your firm concluded that these … results were within the accepted variation of the analytical method and that the quality of these batches was not affected,” the FDA letter stated. “We disagree with your rationale and conclusion. An assay test is used to determine potency, not method variability.”

Rose Talarico, a spokeswoman for Bayer, told Reuters that the company was preparing a response to the FDA. “Based on our assessment at this point in time, we have identified no safety and efficacy impact on our products in relation to the [good manufacturing practice] issues as cited by the FDA,” she said.

The FDA warning to Bayer concerning its API testing wasn’t the first time the agency has found the company in violation of federal regulations. Last October, the FDA cited Bayer for false and misleading television advertisements that promoted Yaz for conditions for which it wasn’t approved, exaggerated its effectiveness, and downplayed the risks associated with the drug. FDA pressure prompted Bayer to launch another American ad campaign correcting the misrepresentations of the earlier ads.

Michael A. Santoro, an associate professor of ethics at the Rutgers Business School who studies pharmaceutical industry ethics, told the New York Times that the FDA warnings about quality control and advertising raise a red flag about Bayer’s attitude in complying with federal regulations. Santoro said that drug manufacturers ought to set higher standards for themselves than those established by the federal government.

“It tells me that [Bayer] is not understanding the business that it is in, that it is not understanding the health risks that it is posing to the public or the financial risk that it is creating for its shareholders,” Santoro told the New York Times.

His concerns seems to be bolstered by the growing number of Yaz lawsuits filed against Bayer in the U.S., which currently stand at 74. Some of the lawsuits have been filed by women allegedly harmed by Yaz who claim they were drawn to the drug because of Bayer’s misleading direct-to-consumer television ads.

SOURCE: Yaz Lawsuit › Yaz testing and marketing raises ethical red flag

All of the lawsuits allege that Yaz and Yasmin caused adverse events attributable to the ingredient drospirenone (DRSP), which has been linked to blood clots, strokes, heart attacks, gall bladder disease, deep vein thrombosis, pulmonary embolism, and other serious reactions, including sudden death. The suits assert that Bayer knew about the risks but failed to disclose them to consumers while at the same time aggressively marketing the drug.

Last year, the U.S. Food and Drug Administration warned Bayer that its television advertisements for Yaz were misleading and failed to disclose all of the drug’s risks.

Traditional birth control drugs do not contain DRSP, which is a new type of progestin that influences the body’s natural ability to balance salt and water, which could adversely lead to elevated potassium levels. Excessive potassium levels in the body may trigger fatal cardiac arrhythmia and other serious health problems.

The FDA received more than 50 reports of deaths linked to Yaz and Yasmin between 2004 and 2008. The fatalities involved heart attacks, pulmonary embolisms, and strokes. Excessive blood potassium levels were found in many of the cases.

A U.S. Judicial Panel on Multidistrict Litigation has scheduled a hearing for September 24 to decide if the Yaz and Yasmin lawsuits currently pending in federal courts are similar enough to be consolidated into an MDL (multi-district litigation).

SOURCE: Yaz Lawsuit › Yaz lawsuits consolidated in Pennsylvania

The “deviations,” as the FDA called them, were cited in a letter dated September 9th and sent to Dr. Franz-Josef Renneke, the Site Manager of Bayer’s plant in Bergkamen, Germany. The FDA published the letter on its website this week.

The FDA found that Bayer tested the quality of some drug ingredients, including drospirenone, a main ingredient in Yaz, using a method the U.S. does not accept. The method involves averaging a group of several samples, rather than providing test results for each ingredient batch. The U.S. requires foreign pharmaceutical manufacturers to conform to American standards when testing the quality of its U.S.-bound exports.

Earlier this year, the FDA warned Bayer that it exported ingredients to the U.S. between 2007 and 2009 yet failed to test them using U.S.-approved methods. Bayer responded in April that it had analyzed all relevant batches and concluded that their quality “was not affected.”

That’s beside the point, the FDA’s letter last week said.

“Your firm concluded that these … results were within the accepted variation of the analytical method and that the quality of these batches was not affected,” the FDA letter stated. “We disagree with your rationale and conclusion. An assay test is used to determine potency, not method variability.”

Yaz and Yasmin were Bayer HealthCare’s best-selling drugs last year, with sales reaching $1.8 billion worldwide.

The FDA has not discovered quality problems in the German imports and does not advise consumers taking Yaz to stop. The FDA’s warning is meant to prevent quality problems from occurring in the future.

According to the Associated Press, “The FDA regularly issues warning letters to companies that do not follow regulations for manufacturing and marketing. The letters are not legally binding, but the agency can take companies to court if they are ignored.”

SOURCE: Yaz Lawsuit › Yaz ingredient not properly tested, FDA warns Bayer